BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3031037 · Received March 28, 2013

    Report

    Report Number
    2242352-2013-00300
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR. LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III SEAL FAILED TO LOAD PROPERLY AND WERE OBSERVED TO BE CRACKED. THE SEAL DID NOT FOLD CORRECTLY DURING THE LOADING PROCESS CAUSING IT NOT TO LOAD PROPERLY INTO THE DELIVERY DEVICE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127810 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR. LLC HS-3045 25070086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA